A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B Infection

Treatments: Biological: V232 Modified Process Hepatitis B Vaccine: Lot B; Biological: V232 Modified Process Hepatitis B Vaccine: Lot C; Biological: V232 Current Process Hepatitis B Vaccine; Biological: V232 Modified Process Hepatitis B Vaccine: Lot A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00489099

2007_565

V232-054

Details and patient eligibility

About

A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.

Enrollment: 860 patients

Sex: All

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In general good health
• Female participants have a negative pregnancy test just prior to vaccination on Day 1

Exclusion criteria

• History of Hepatitis B Infection or vaccination
• Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast)
• Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1
• Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1
• Participation on prior study using an investigational drug or vaccine in prior 3 months
• Known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids
• Pregnant or nursing women or women planning to become pregnant within the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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860 participants in 4 patient groups

V232 Modified Process Hepatitis B Vaccine: Lot A

Experimental group

Description:

Recombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.

Treatment:

Biological: V232 Modified Process Hepatitis B Vaccine: Lot A

V232 Modified Process Hepatitis B Vaccine: Lot B

Experimental group

Description:

Recombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.

Treatment:

Biological: V232 Modified Process Hepatitis B Vaccine: Lot B

V232 Modified Process Hepatitis B Vaccine: Lot C

Experimental group

Description:

Recombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.

Treatment:

Biological: V232 Modified Process Hepatitis B Vaccine: Lot C

V232 Current Process Hepatitis B Vaccine

Active Comparator group

Description:

Recombivax HB™ (Hepatitis B Vaccine \[Recombinant\]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.

Treatment:

Biological: V232 Current Process Hepatitis B Vaccine